Summary VisionQuest Biomedical LLC (VisionQuest) has developed a diabetic retinopathy (DR) screening system (EyeStar?) enabled by automated screening software (DR-RACS) that was developed under the EY018280 Phase II SBIR project. Our product provides immediate feedback to the physician on the state of diabetic eye disease without burdening an eye care specialist to review those cases without retinal disease. Diabetes affects over 29 million Americans, and DR is one of its main complications. If not detected early, DR leads to vision loss and blindness. With the number of diabetics projected to grow to over 50 million by 2025, worldwide DR has become a serious healthcare concern. DR- RACS will improve DR screening rates by providing a solution that is low-cost and integrated at the point of care, and that will result in increased revenues for insurance companies and healthcare providers. The main objective of this grant application is to complete the final steps needed to commercialize VisionQuest?s EyeStar? DR screening system. For commercialization, VisionQuest requires FDA clearance of the enabling component, the DR-RACS software. This objective will be achieved through two specific aims. In Aim 1 we will make VisionQuest and the DR-RACS product compliant with the quality system regulations (QSR) in preparation for regulatory submissions. In Aim 2 we will prepare DR-RACS for FDA 510(k) submission. To achieve this goal, we will prepare a 510(k) pre-submission, carry out a multi-center clinical study, and submit a De Novo/510(k) application to the FDA. At the completion of this project, we will have the first FDA-cleared automated DR screening software. We will then be positioned to commercialize our automatic retinal screening system, EyeStar?, to serve the needs of the healthcare industry in the US and worldwide.